PrecisionTAVI

GUDID 00860011603207

PrecisionTAVI

DasiSimulations LLC

Radiology DICOM image processing application software
Primary Device ID00860011603207
NIH Device Record Key687ebebe-b575-429f-a57a-3ba3115e3004
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecisionTAVI
Version Model Number1.1
Company DUNS117358030
Company NameDasiSimulations LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011603207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QQIInterventional Cardiovascular Implant Simulation Software Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07

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